[Federal Register Volume 64, Number 112 (Friday, June 11, 1999)]
[Notices]
[Page 31600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14824]



[[Page 31600]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


The National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK) of the National Institutes of Health (NIH) Announces 
the Opportunity for Clinical Trial Agreements (CTA) in Conjunction with 
a Major Multicenter Clinical Trial Aimed at Developing Practical, Safe 
and Effective Means of Preventing the Progression of Liver Disease in 
Patients With Chronic Hepatitis C Virus (HCV) Infection

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: The National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK) seeks capability statements from parties interested in 
entering into a potential Clinical Trial Agreement (CTA) to provide 
agent for treating subjects in the Hepatitis C Clinical Trial (HCCT). 
Collaborator applicants developing capability statements must also 
include plans for packaging, labeling, and distributing agent and 
placebo. The primary criterion for selecting a potential Collaborator 
is the scientific merit of proposals for use of preventing the 
progression of liver disease in patients with chronic hepatitis C virus 
infection.
    The control of the HCCT shall reside entirely with the Institute 
and the scientific participants of the trial. In the event that any 
adverse effects are encountered which, for legal or ethical reasons, 
may require communication with the FDA, the relevant collaborating 
institutions will be notified. Neither the conduct of the trial nor the 
results should be represented as a NIDDK endorsement of the drug under 
study.

DATES: Only written Capability Statements received by the NIDDK on or 
before August 1, 1999 will be considered during the initial design 
phase. Potential Collaborators may be invited to meet with the 
Selection Committee at the Collaborator's expense to provide additional 
information. The Institute may issue an additional notice of 
opportunity during the design of the trial if circumstances change or 
if the trial design alters substantially.

FOR ADDITIONAL INFORMATION AND QUESTIONS: Capability statements should 
be submitted to Dr. Michael W. Edwards, Office of Technology 
Development, National Institute of Diabetes and Digestive and Kidney 
Diseases, National Institutes of Health, BSA Building, Suite 350 MSC 
2690, 9190 Rockville Pike, Bethesda, MD 20814-3800; Tel: 301/496-7778, 
Fax: 301/402-0535; Email:[email protected].

SUPPLEMENTARY INFORMATION: The HCCT will be conducted as collaborative 
contracts among nine (9) Clinical Centers (CCs) a central data 
coordinating (DCC) with biostatistical expertise and with input from a 
hepatologist, and a central virological testing laboratory (VL). The 
HCCT will be designed to evaluate whether continuous long-term 
antiviral therapy can slow the progression of liver disease, preventing 
cirrhosis or preventing worsening of cirrhosis, decompensation, 
development of hepatocellular carcinoma (HCC) and death from liver 
disease. The Trial will also evaluate the natural history of hepatitis 
C and the factors that predict or correlate with disease progression. 
The major focus will be to evaluate whether antiviral therapy, despite 
not leading to eradication of HCV, can suppress hepatocellular injury, 
necrosis and fibrosis.
    HCCT is expected to recruit approximately 800 patients with chronic 
hepatitis C who have failed to respond to therapy with alpha interferon 
(with or without ribavirin) and who have significant fibrosis on liver 
biopsy. The carefully designed cohort of patients will be enrolled in a 
study of the efficacy and safety of a continuous long-term antiviral 
therapy (for as long as four years)

Capability Statements

    The design concept described above is not final. The final design 
will be developed over the course of the first year of the trial by the 
HCCT Steering Committee (which will include the Principal Investigators 
of the Clinical Centers, the Data Coordinating Center, the Virology 
Laboratory and the NIDDK Project Officer). It is possible that the 
final design for HCCT may include more than one agent.
    A Selection Committee will utilize the information provided in the 
``Collaborator Capability Statements'' received in response to this 
announcement to help in its deliberations. The Selection Committee will 
interact with the Steering Committee to develop the most appropriate 
design, based on a thorough understanding of the efficacy and side 
effects associated with all agents proposed.
    It is the intention of the NIDDK that qualified Collaborators have 
the opportunity to provide information to the Selection Committee 
through their capability statements. The Capability Statement should 
not exceed 8 pages and should address the following selection criteria:
    (1) The statement should provide specific details regarding the 
safety and efficacy of the proposed agent for long-term use in 
hepatitis C patients.
    (2) The statement should include a detailed plan demonstrating the 
ability of the Collaborator to provide sufficient quantities of the 
agent in a timely manner for the duration of the study.
    (3) The statement should outline plans for packaging, labeling, and 
distributing the agent along with placebo. The statement should 
describe the commitment of other resources such as scientific research, 
personnel, services, facilities, or equipment that would be used to 
support conduct of the trial.
    (4) The statement must address willingness to promptly publish 
research results and ability to be bound by PHS policies.

    Dated: June 4, 1999.
L. Earl Laurence,
Deputy Director, National Institute of Diabetes and Digestive and 
Kidney Diseases, National Institutes of Health.
[FR Doc. 99-14824 Filed 6-10-99; 8:45 am]
BILLING CODE 4140-01-M